Newsletter | November 21, 2019

11.21.19 -- 9 Bills That Could Impact Biologic Patent Disputes

Featured Editorial
Sterile Injectable Outsourcing Trends: What Biosimilar Developers Must Know
By Anna Rose Welch, editor, Biosimilar Development

Though a majority of the data points in a recent ISR report on sterile manufacturing are not specifically focused around biosimilars, I reached out to the report’s lead author to unpack a handful of findings I thought would be important for those involved in both biologics and biosimilar manufacturing and outsourcing.

Legislation To Watch: 9 Proposed Bills Impacting Biologics And Patent Disputes
By E. Blais, N. Mitrokostas, and J. Weinger, Goodwin Procter

Legislators from both parties have been actively proposing new legislation that could impact biologics and the market for biosimilars in the United States. Although these proposed bills have taken a variety of approaches, they are principally focused on market access and pricing of biologic drugs.

Biologics Pricing: A Deep-Dive Into Dynamics And Behaviors Over Time
By Edric Engert, Abraxeolus Consulting

In this second part of a two-part series we’ll dive into some of the details and datasets behind pharmaceutical pricing, trends, and behaviors in an effort to move toward effective cost management, economic sustainability, and continued U.S. pharmaceutical innovation.

Industry Insights
Purification Of Antibodies With Nuvia aPrime 4A Hydrophobic Anion Exchange Resin
Application Note | By X. He, L. Vang, M. Syder, P. Khandelwal, and D.Yoshikawa, Bio-Rad Laboratories, Inc.

A hydrophobic anion exchange mixed-mode resin has been developed to overcome challenges in antibody purification. This application note describes the purification of acidic and basic antibodies using this mixed-mode chromatography resin through bind-elute and flow-through modes of purification.

Best Practices For A Successful Bioprocess Technology Transfer
Article | GE Healthcare Life Sciences

A well-executed bioprocess tech transfer is critical to ensure smooth knowledge transfer and optimal process reproducibility. If not executed properly, you risk reducing the quality and efficiency of your process. If you waste time troubleshooting, you may delay your time-to-market. In today’s global markets effective tech transfer is critical.

  Festival Of Biologics USA

March 2 to 4, 2020 | Loews Resort Coronado, San Diego

The Festival of Biologics brings together senior biologics professionals to showcase their research, collaborate on challenges, forge new connections, and ultimately advance the industry to improve patient health. It is the meeting place for the life sciences community to bridge the gap between academia and industry. With three events in one, the Festival of Biologics encourages conversation across the entire industry so you can inspire change, champion innovation, and address complex challenges.

Your 15% discount code is: BIODEV15

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